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Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment


N/A
18 Years
85 Years
Open (Enrolling)
Both
Colorectal Cancer, Skin Toxicities

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Trial Information

Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment


Patients with metastatic colorectal cancer treated with cetuximab or panitumumab usually
develop the skin toxicity which can impair patients' quality of life as well as limit the
treatment. We designed this trial to assess the effect of simplified protocol of pre-emptive
treatment on the observed skin toxicities during cetuximab and panitumumab treatment of
colorectal cancer.

The study is a cohort observational, single center study which should result in estimation
of particular types of toxicities, especially occurence of more severe (grade 2 and 3) side
effects and assess the tolerance of doxycyline in the prolonged administration.

The observation in the study is biweekly and is continued up to 8 weeks.


Inclusion Criteria:



- diagnosis of metastatic colorectal cancer,

- previously qualified to either cetuximab or panitumumab,

- written consent.

Exclusion Criteria:

- previous administration of cetuximab or panitumumab,

- contradictions to receive oral doxycycline.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

number of patients with a severe skin toxicity

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Lucjan S Wyrwicz, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Authority:

Poland: Ethics Committee

Study ID:

STLDD-1

NCT ID:

NCT01380262

Start Date:

June 2010

Completion Date:

September 2011

Related Keywords:

  • Colorectal Cancer
  • Skin Toxicities
  • Colorectal Cancer
  • Skin Rash
  • Pre-emptive treatment
  • Doxycycline
  • Anti-EGFR antibody
  • Cetuximab
  • Panitumumab
  • Colorectal Neoplasms

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